Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00087399

Collaborator

National Cancer Institute (NCI) (NIH)

118

Enrollment

162

Locations

Arms

28.9

Duration (Months)

0.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes.

PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Hot Flashes	Drug: gabapentin Drug: antidepressant	Phase 3

Detailed Description

OBJECTIVES:

Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer.
Compare adverse events in patients treated with these regimens.
Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity.
Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule).

Patients in both arms complete a hot flash diary at baseline and then daily during study treatment.

Quality of life is assessed at baseline and then weekly during study treatment.

PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gabapentin + antidepressant Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients complete a hot flash diary at baseline and then daily during study treatment.	Drug: gabapentin Drug: antidepressant
Experimental: gabapentin Patients receive gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone. Patients complete a hot flash diary at baseline and then daily during study treatment.	Drug: gabapentin

Arm

Intervention/Treatment

Experimental: gabapentin + antidepressant

Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients complete a hot flash diary at baseline and then daily during study treatment.

Drug: gabapentin

Drug: antidepressant

Experimental: gabapentin

Patients receive gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone. Patients complete a hot flash diary at baseline and then daily during study treatment.

Drug: gabapentin

Outcome Measures

Primary Outcome Measures

Hot flash reduction by diary record at 4 weeks [at 4 weeks]

Secondary Outcome Measures

Toxicity by questionnaires at 4 weeks [at 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer
Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant
Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant
No monoamine oxidase inhibitors or tricyclics
No current evidence of malignant disease
Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Performance status

ECOG 0-1

Life expectancy

At least 6 months

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy

More than 4 weeks since prior antineoplastic chemotherapy
No concurrent antineoplastic chemotherapy

Endocrine therapy

More than 4 weeks since prior androgens, estrogens, or progestational agents
More than 2 weeks since prior dehydroepiandrosterone (DHEA) for treatment of hot flashes
No concurrent androgens, estrogens, or progestational agents, including oral contraceptives
No concurrent DHEA for treatment of hot flashes
Concurrent tamoxifen, raloxifene, or aromatase inhibitor therapy allowed if on a stable dose for at least 4 weeks prior to study entry and during study treatment

Other

No prior gabapentin
More than 2 weeks since other prior treatment for hot flashes (e.g., clonidine or Bellergal-S®)
Concurrent vitamin E or soy supplements allowed if on a stable dose for at least 1 month prior to study entry and during study treatment
No other concurrent treatment for hot flashes (e.g., clonidine or Bellergal-S®)
No other concurrent antidepressants

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259
2	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224-9980
3	MBCCOP-Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912
4	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
5	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
6	Graham Hospital	Canton	Illinois	United States	61520
7	Memorial Hospital	Carthage	Illinois	United States	62321
8	Eureka Hospital	Eureka	Illinois	United States	61530
9	Galesburg Clinic	Galesburg	Illinois	United States	61401
10	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
11	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois	United States	61401
12	Mason District Hospital	Havana	Illinois	United States	62644
13	Hopedale Medical Complex	Hopedale	Illinois	United States	61747
14	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
15	Kewanee Hospital	Kewanee	Illinois	United States	61443
16	McDonough District Hospital	Macomb	Illinois	United States	61455
17	Trinity Medical Center - East	Moline	Illinois	United States	61265
18	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
19	Community Cancer Center	Normal	Illinois	United States	61761
20	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
21	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois	United States	61350
22	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
23	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61603
24	Proctor Hospital	Peoria	Illinois	United States	61614
25	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
26	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61615
27	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
28	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
29	Perry Memorial Hospital	Princeton	Illinois	United States	61356
30	St. Margaret's Hospital	Spring Valley	Illinois	United States	61362
31	Valley Cancer Center	Spring Valley	Illinois	United States	61362
32	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
33	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
34	St. Francis Hospital and Health Centers	Beech Grove	Indiana	United States	46107
35	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
36	McFarland Clinic, P.C.	Ames	Iowa	United States	50010
37	Saint Anthony Regional Hospital	Carroll	Iowa	United States	51401
38	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
39	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
40	Mercy Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
41	Alegent Health Mercy Hospital	Council Bluffs	Iowa	United States	51503
42	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
43	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
44	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
45	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
46	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
47	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
48	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
49	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
50	Alegent Health Community Memorial Hospital	Missouri Valley	Iowa	United States	51555
51	Burgess Health Center	Onawa	Iowa	United States	51040
52	Cancer Center at Ottumwa Regional Health Center	Ottumwa	Iowa	United States	52501
53	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101-1733
54	Siouxland Hematology-Oncology Associates	Sioux City	Iowa	United States	51101
55	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
56	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
57	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
58	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
59	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
60	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas	United States	67042
61	Cancer Center of Kansas - Kingman	Kingman	Kansas	United States	67068
62	Southwest Medical Center	Liberal	Kansas	United States	67901
63	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
64	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas	United States	67357
65	Pratt Cancer Center of Kansas	Pratt	Kansas	United States	67124
66	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67042
67	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
68	Associates in Womens Health	Wichita	Kansas	United States	67203
69	Cancer Center of Kansas, P.A.	Wichita	Kansas	United States	67208
70	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas	United States	67214
71	CCOP - Wichita	Wichita	Kansas	United States	67214
72	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
73	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
74	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48100
75	St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
76	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
77	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48532
78	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan	United States	49801
79	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48909
80	Seton Cancer Institute - Saginaw	Saginaw	Michigan	United States	48601
81	St. John Macomb Hospital	Warren	Michigan	United States	48903
82	MeritCare Clinic - Bemidji	Bemidji	Minnesota	United States	56601
83	Brainerd Medical Center	Brainerd	Minnesota	United States	56401
84	St. Joseph's Medical Center	Brainerd	Minnesota	United States	56401
85	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
86	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
87	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
88	Mercy and Unity Cancer Center at Mercy and Unity Hospitals	Fridley	Minnesota	United States	55432
89	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
90	Meeker County Memorial Hospital	Litchfield	Minnesota	United States	55355
91	St. John's Hospital	Maplewood	Minnesota	United States	55109
92	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
93	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
94	Chippewa County - Montevideo Hospital	Montevideo	Minnesota	United States	56265
95	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422
96	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
97	St. Cloud Hospital	Saint Cloud	Minnesota	United States	56303
98	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
99	Cancer Care Center at Regions Hospital	Saint Paul	Minnesota	United States	55101
100	Saint Francis Cancer Center	Shakopee	Minnesota	United States	55379
101	St. Joseph's Hospital	St Paul	Minnesota	United States	55102
102	Adult and Pediatric Urology, P.L.L.P.	St. Cloud	Minnesota	United States	56303
103	CentraCare Clinic - River Campus	St. Cloud	Minnesota	United States	56303
104	Park Nicollet Clinic	St. Louis Park	Minnesota	United States	55416
105	United Hospital	St. Paul	Minnesota	United States	55102
106	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
107	Woodwinds Hospital	Woodbury	Minnesota	United States	55125
108	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
109	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59101
110	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
111	St. Vincent Healthcare	Billings	Montana	United States	59101
112	Deaconess Billings Clinic Cancer Center	Billings	Montana	United States	59107
113	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
114	St. James Community Hospital	Butte	Montana	United States	59701
115	Great Falls Clinic	Great Falls	Montana	United States	59405
116	Sletten Regional Cancer Institute	Great Falls	Montana	United States	59405
117	St. Peter's Hospital	Helena	Montana	United States	59601
118	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
119	Eastern Montana Cancer Center	Miles City	Montana	United States	59301
120	Community Medical Center	Missoula	Montana	United States	59801
121	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59802
122	Fremont Area Medical Center	Fremont	Nebraska	United States	68025
123	Bryan LGH Medical Center West	Lincoln	Nebraska	United States	68502
124	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
125	St. Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
126	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
127	Immanuel Medical Center	Omaha	Nebraska	United States	68122
128	Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
129	Cancer Center at Creighton University Medical Center	Omaha	Nebraska	United States	68131
130	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska	United States	68046
131	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
132	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
133	Medcenter One Health System	Bismarck	North Dakota	United States	58501
134	Mid Dakota Clinic, P.C.	Bismarck	North Dakota	United States	58501
135	St. Alexius Medical Center	Bismarck	North Dakota	United States	58501
136	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
137	MeritCare Medical Group	Fargo	North Dakota	United States	58122
138	Grandview Hospital	Dayton	Ohio	United States	45405
139	Good Samaritan Hospital	Dayton	Ohio	United States	45406
140	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
141	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
142	CCOP - Dayton	Dayton	Ohio	United States	45429
143	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
144	Middletown Regional Hospital	Middletown	Ohio	United States	45044
145	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373
146	United States Air Force Medical Center Wright-Patterson	Wright-Patterson Afb	Ohio	United States	45433-5529
147	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
148	John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18105
149	Guthrie Medical Center - Sayre	Sayre	Pennsylvania	United States	18840
150	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina	United States	29621
151	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
152	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29304
153	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57104
154	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota	United States	57105
155	Medical X-Ray Center	Sioux Falls	South Dakota	United States	57105
156	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
157	St. Vincent Hospital	Green Bay	Wisconsin	United States	54301
158	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
159	St. Mary's Hospital Medical Center	Green Bay	Wisconsin	United States	54303
160	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
161	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
162	Welch Cancer Center	Sheridan	Wyoming	United States	82801